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NCT Number: NCT04220905

Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.

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Key information

Conditions

Colonic Polyp Colonic Polyps Colonoscopy Complication Disease Attributes Duodenal Polyp Intestinal Polyps Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Over recent years, a number of studies have been published that have highlighted factors associated with improved efficacy and safety of large polyp resection. Almost all of these studies originate from one large Australian cohort. It is unclear, whether the results are generalizable to other populations. It is important to understand if these findings can be duplicated, to further build on the gained knowledge. At the same time the technology of endoscopic resection is evolving.

Established in 2012, the Large Polyp Study group aims to prospectively examine outcomes related to endoscopic large polyp removal. Enrollment of an ongoing randomized trial of 920 patients has just been completed and a second trial is planned. The primary aim of both trials is to understand whether a specific intervention will reduce the risk of adverse events. The added observational study will complement the trials in different ways: It will enroll patients who might not have been eligible for the trials and allow the application of other resection techniques. The observational study will therefore better represent the average patient who undergoes resection of a large polyp. Furthermore, it will add sample size to examine secondary outcomes with greater power.

This is a continuation of NCT01936948 (Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial) as a observational cohort.

The continuation was approved by the institutional IRB as part of the initial RCT. At this point the investigators document the observational arm as its own study in this registry.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion
  • Patients with a ≥20mm colon polyp
  • Patients with a ≥10mm duodenal polyp

Exclusion criteria

  • Patients who are receiving an emergency endoscopy
  • Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
  • Poor bowel preparation
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Incidence of severe complications

    Time frame: Up to 14 days following the procedure.

    Aggregate of all severe adverse events that occur at the time of the procedure or during and up to 14 days of follow-up. Severe adverse events include bleeding, perforation, postpolypectomy syndrome, and clinical events that require an admission to the hospital.

  2. Completeness of polyp resection

    Time frame: During the procedure

    Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.

  3. Polyp recurrence

    Time frame: Up to 5 years (at next scheduled surveillance colonoscopy).

    Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.

Secondary outcomes

  1. Severe bleeding complications

    Time frame: Up to 14 days following the procedure.

    Severe bleeding is defined as the need for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology, up to 14 days following the procedure.

  2. Perforation

    Time frame: Up to 14 days following the procedure.

    Defined as a complete hole, or full-thickness resection of the muscularis propria (Sydney Classification of Deep Mural Injury Type IV)

  3. Postpolypectomy syndrome

    Time frame: Following the procedure up to 14 days.

    Defined as abdominal pain severe enough to warrant an ED visit or hospital admission and presence of leukocytosis and/or required treatment with antibiotics.

  4. Efficacy of submucosal injectate

    Time frame: During the procedure.

    Volume of solution per lesion size (mL/cm2), time of resection.

  5. Intraprocedural bleeding

    Time frame: During the procedure

    Immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g. clip placement or snare tip soft coagulation or coagulation grasper).

  6. Need for colon resection

    Time frame: Up to 3 years following the procedure.

    Patients who require surgery for polyp removal or as a result of complications related to the EMR or follow up procedures.

  7. Technical skill of the endoscopist

    Time frame: During the procedure

    To perform video based assessment of endoscopic resection skills

  8. Cold snare of duodenal adenomas greater than 10 mm

    Time frame: Up to 3 years following baseline procedure

    Safety, efficacy, recurrence of neoplastic polyp at first surveillance endoscopy, serious adverse events

  9. Cold snare of Paris IIa polyps greater than 20 mm

    Time frame: 1 year following baseline procedure

    Safety, efficacy, recurrence, serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Heiko Pohl, MD

CONTACT

[email protected]

8022959363

Laura L Jensen, MPH

CONTACT

[email protected]

802-295-9363 ext. 6953

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Registry information

Official study title

Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2020
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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